Antenatal anti-D prophylaxis and D antigen negativity in pregnant women of the UAE: a cross-sectional analysis from the Mutabaah Study

Objective
This study aimed to determine the prevalence of the negative D antigen phenotype, adherence to routine antenatal anti-D immunoglobulin prophylaxis (RAADP) administration and D antigen sensitisation among pregnant women in the UAE.

Design
Data was collected from pregnant women enrolled in the Mutaba’ah Study. The Mutaba’ah Study is an ongoing prospective mother and child cohort study in the UAE. Data were extracted from the medical records and baseline questionnaire administered to the participants between May 2017 and January 2021.

Setting
The study was conducted in Al Ain city of the UAE.

Participants
A total of 5080 pregnant women residing in Al Ain participated in the study.

Outcome measures
The study estimated the prevalence of negative D antigen phenotype and the provision of RAADP in this population.

Results
Of the 5080 pregnant women analysed, 4651 (91.6%) had D antigen positive status, while 429 (8.4%) were D-negative. D antigen sensitisation was low at 0.5%, and there was a high uptake of RAADP in the population at 88.8%.

Conclusions
The adherence to RAADP is consistent with published data from other healthcare settings. Knowledge of the prevalence of D antigen negative mothers is crucial to the financial and resource consideration for implementing antenatal foetal cell-free DNA screening to determine foetal D antigen status.

Leggi
Ottobre 2024

Treatments, medical expenses and complications of hospital outpatient healthcare associated with stroke in patients with diabetes in China: a retrospective analysis of the Beijing Municipal Medical Insurance Database

Objectives
Diabetes is closely associated with risk of stroke and its adverse sequelae. Approximately 20%–33% of patients with stroke have diabetes. In China, however, it is unclear how stroke affects healthcare utilisation, medications and complications among people with diabetes. This study aimed to analyse the clinical characteristics, treatment options, medical expenses and complications of hospital outpatient healthcare associated with stroke in patients with diabetes in China.

Design
A retrospective, multicentre, observational study.

Setting
Beijing Municipal Medical Insurance Database, with data from 2016 to 2018.

Participants
The study included patients with diabetes whose data included 2016–2018 outpatient medication records and who had Beijing medical insurance. Patients who did not have continuous prescription records for more than 2 months were excluded from the analysis. In total, 2 853 036 people with diabetes were included, and patients who had and did not have a stroke were compared.

Results
In our study, 19.75%–22.30% of patients with diabetes suffered from stroke between 2016 and 2018. The average annual medical cost for a patient diagnosed with diabetes is ¥9606.65, and the cost increases to ¥13 428.39 when diabetes was combined with stroke; thus, stroke increases the medical cost for patients with diabetes by 39.78% (p

Leggi
Ottobre 2024

Real-world safety profile of zanubrutinib: a disproportionality analysis based on the FAERS database

Objective
Zanubrutinib is a second-generation Bruton’s tyrosine kinase inhibitor that has been approved for the treatment of several B cell malignancies. The aim of this study was to evaluate adverse events (AEs) associated with zanubrutinib based on the real-world data.

Design
A disproportionality analysis was performed to identify the potential zanubrutinib-related AEs.

Setting
The Food and Drug Administration AE Reporting System database from the fourth quarter of 2019 to the third quarter of 2023.

Main outcome measures
The results of the disproportionality analyses were presented as reported ORs (RORs). When the lower limit of the 95% CI for the ROR is greater than 1 and the number of AE reports is≥3, it indicates that the preferred term (PT) may be a positive AE signal.

Results
A total of 846 AE reports with zanubrutinib as the primary suspect drug were obtained, with 2826 AEs. A total of 74 positive PT signals were detected across 18 system organ classes (SOCs). The most significant signal for SOC was ‘blood and lymphatic system disorders’ (ROR=2.8, 95% CI 2.3 to 3.3), while the most significant signal for PT was ‘haemorrhage subcutaneous’ (ROR=190.8, 95% CI 128.0 to 284.5). 13 unexpected off-label AEs were also observed, such as abnormal hair texture, skin discolouration, hypernatraemia, pericardial effusion and hypersomnia. The median time to onset of AEs associated with zanubrutinib was 51 days (IQR 13–192 days) and was consistent with the early failure model. In comparison with zanubrutinib monotherapy, the combination of zanubrutinib and rituximab therapy was linked to a higher risk of specific AEs, including myelosuppression, pneumonia, leucopenia, thrombocytopenia, abdominal pain, anaemia, pancytopenia and respiratory failure. Furthermore, the combination of zanubrutinib and chemotherapy increased the risk of several severe AEs, such as cardiac arrest, elevated blood lactate dehydrogenase levels and pancytopenia.

Conclusions
The results of the analysis provided valuable insights into the safety profile of zanubrutinib-treated patients, which was helpful for clinical monitoring and identifying potential AEs related to zanubrutinib.

Leggi
Ottobre 2024

Akrivia Health Database–deep patient characterisation using a secondary mental healthcare dataset in England and Wales: cohort profile

Purpose
The Akrivia Health cohort was created to extract data from electronic health records in secondary mental health and dementia care services in England and Wales. The data are anonymised, structured and harmonised from the source electronic health records across a range of information technology systems, enabling for unified, privacy-preserving access for research purposes.

Participants
The cohort contains data from electronic health records for over 4.6 million patients in England and Wales, as of January 2024. The data are refreshed with regularity, and the dataset expands whenever a new healthcare provider joins the Akrivia network. 13% of the database are patients under 18 years old (n=590 160), 56% are adults 18–65 years old (n=2 631 690) and 31% are older people (n=1 422 609). About 11.5% are deceased (n=538 371).

Findings to date
Structured data include patient demographics and service pathways. Akrivia Health also uses a bespoke natural language processing model to further extract the research-relevant information from free-text progress notes, including diagnoses, medications and clinical symptoms. This allows for an in-depth longitudinal description of patient journeys.

Future plans
The anonymised data can be accessed in collaboration with Akrivia Health, following the National Health Service guidelines and without requiring a separate ethics application. There is no planned end date for data collection.

Leggi
Ottobre 2024

Effect of telemonitoring on the rate of dropout during home non-invasive ventilation: a retrospective study using a home care provider database

Objectives
Telemonitoring (TM) of home non-invasive ventilation (NIV) has been shown to facilitate home/outpatient therapy set-up. However, the impact of long-term TM on therapy dropouts, compliance and leak control has not yet been clearly determined. This study evaluated whether the NIV dropout rate was reduced by TM combined with remote patient support compared with a non-telemonitoring (NTM) pathway.

Design
Retrospective cohort study.

Setting
Data were obtained from all agencies of a single home care provider in France.

Participants
Adults with chronic respiratory failure (n=659) who started nocturnal NIV between January 2017 and December 2019 and had ≥8 days of NIV therapy (51% male; mean age 68.5±13.8 years; 35.5% on long-term oxygen therapy) were included. The TM group included 275 patients who spent ≥80% of the follow-up using TM, and the NTM group included 384 patients who had 0 to ≤10 days of telemonitoring during follow-up.

Primary and secondary outcome measures
The primary outcome was the rate of NIV dropouts at 1 year (ie, treatment discontinuation, excluding deaths). Secondary outcomes included therapy compliance and leaks.

Results
82 patients died during follow-up. Significantly fewer patients in the TM vs NTM group had dropped out of NIV therapy at 1 year (13% vs 34%; p

Leggi
Ottobre 2024